Quality & compliance

FDA logs Class II recall of Carolina Infusion's compounded tirzepatide/cyanocobalamin injectable over sterility assurance

The compounded injectable is recalled nationwide in the US after the FDA cited a lack of assurance of sterility linked to bacteriostatic water and processing equipment.

FDA lists Class II recall of K.C. Pharmaceuticals' Eye Drops MAXIMUM over sterility assurance

The US enforcement report records an ongoing, nationwide recall of Eye Drops MAXIMUM, citing lack of assurance of sterility.

FDA logs Class II recall of Carolina Infusion's compounded tirzepatide/cyanocobalamin injectable over sterility assurance

Carolina Infusion's tirzepatide/cyanocobalamin injectable is the subject of an ongoing nationwide US recall, with FDA citing a lack of assurance of sterility.

FDA lists Class II recall of K.C. Pharmaceuticals lubricating eye drops over sterility assurance

The agency's enforcement report records an ongoing nationwide recall of Sterile High Performance Ultra Lubricating Eye Drops, citing lack of assurance of sterility.

FDA logs Class II recall of compounded tirzepatide/cyanocobalamin injection over sterility assurance concerns

Carolina Infusion's compounded tirzepatide and cyanocobalamin injectable is subject to an ongoing nationwide US recall, recorded as D-0030-2027, due to a lack of assurance of sterility.

FDA classifies Carolina Infusion Tri-Mix compounded drug recall as Class II over sterility assurance

Carolina Infusion's Tri-MIX (PAPAV/PHENTO/ALPROS) is under an ongoing nationwide US recall, with FDA citing a lack of assurance of sterility.

FDA classifies Preferred Pharmaceuticals lidocaine ointment recall as Class II over content uniformity failure

The nationwide US recall of Lidocaine Ointment USP, numbered D-0013-2027, was logged in the FDA enforcement report on 14 October 2026 and remains ongoing.

FDA lists Class II recall of Apothecary Pharma's tirzepatide injection over sterility assurance

The enforcement report entry, numbered D-0036-2027, cites lack of assurance of sterility and records the nationwide recall as ongoing.

FDA lists Class II recall of K.C. Pharmaceuticals sterile eye drops over sterility assurance

The US regulator's enforcement report records an ongoing nationwide recall, D-0007-2027, for sterile eye drops from K.C. Pharmaceuticals, Inc., citing a lack of assurance of sterility.

FDA classifies IMAAVY (nipocalimab-aahu) injection recall as Class II over particulate matter

Johnson & Johnson Innovative Medicine's IMAAVY injection is subject to an ongoing recall, numbered D-0016-2027, after particulate matter was identified, with distribution recorded in Ohio.

FDA lists Class II recall of Cipla fosfomycin granules over impurity and degradation failure

Cipla USA's Fosfomycin Tromethamine Granules for Oral Solution are subject to a nationwide Class II recall after failing impurities/degradation specifications, according to FDA's enforcement report.

FDA lists Class II recall of Sterile Eye Drops Advanced Relief over sterility assurance

K.C. Pharmaceuticals' eye drops are subject to an ongoing nationwide US recall, classified Class II, for lack of assurance of sterility.

FDA lists Class II recall of Carolina Infusion compounded tirzepatide/cyanocobalamin injection over sterility concerns

Carolina Infusion's compounded tirzepatide and cyanocobalamin injectable is subject to an ongoing nationwide US recall, recorded as D-0027-2027, because sterility cannot be assured.

Carolina Infusion recalls compounded quad-mix injectable over lack of sterility assurance

FDA's enforcement report lists a Class II recall of Carolina Infusion's papaverine, phentolamine, alprostadil and trimix-style injectable, citing processing equipment concerns; the recall is ongoing nationwide.

FDA lists Class II recall of K.C. Pharmaceuticals dry eye drops over sterility assurance

The US regulator's enforcement report records an ongoing recall of Sterile Lubricant Dry Eye Relief Eye Drops, distributed nationwide, citing lack of assurance of sterility.

Questions and answers on the PIP compliance verification procedure at EMA, and on paediatric rewards

Class II drug recall: Ranolazine Extended-Release Tablets (Ajanta Pharma Usa Inc)

Failed Dissolution Specifications: below specification Recall D-0010-2027; status Ongoing; distribution: Nationwide in the US..

Class II drug recall: Buprenorphine Hydrochloride (Par Health Usa, Llc)

Crystallization Recall D-0876-2026; status Ongoing; distribution: U.S. Nationwide.

Class II drug recall: Benzoyl Peroxide Wash (Sv Labs Toronto Corporation)

Microbial contamination of topical product. Recall D-0878-2026; status Ongoing; distribution: IL only.

Class II drug recall: Paroxetine Extended-Release Tablets (Apotex Corp.)

Failed dissolution specifications. Recall D-0877-2026; status Ongoing; distribution: US Nationwide..

Class II drug recall: Zoladex (goserelin) implant (Tersera Therapeutics Llc)

Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours. Recall D-0875-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: FOCUS PI Hypromellose 0.7% Formula (Aurolab Trust)

Lack of Assurance of Sterility Recall D-0874-2026; status Ongoing; distribution: VA.

Class II drug recall: Estradiol Gel (Amneal Pharmaceuticals, Llc)

Defective Container; packets were found to be either empty or partially full. Recall D-0873-2026; status Ongoing; distribution: Nationwide in the USA..

Class II drug recall: MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++ (Shantou Qiwei Industrial Co., Ltd)

cGMP Deviations Recall D-0854-2026; status Ongoing; distribution: CA only.

Class II drug recall: Reliable-1 Laboratories Lubricating Tears (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0859-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Clear Eyes Redness Relief (Insight Pharmaceuticals Llc, A Prestige Consumer Healthcare Company)

Lack of Assurance of Sterility Recall D-0870-2026; status Ongoing; distribution: Nationwide in the USA..

Class II drug recall: Walgreens Lubricant Eye Drops (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0857-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Major LubriFresh P.M. Nighttime Ointment (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0861-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Exenatide Injection (Amneal Pharmaceuticals Of New York, Llc)

Defective Delivery System: Possibility of no medication in the prefilled pen. Recall D-0868-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: Reliable -1 Laboratories (Sterling Pharmaceutical Services Llc)

Lack of Assurance of Sterility Recall D-0856-2026; status Ongoing; distribution: USA Nationwide.